FDA Clears Flex Pharma's FLX-787 to Commence US Phase 2 Trial in ALS Under IND
April 26 2017 - 8:00AM
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Flex Pharma, Inc. (NASDAQ: FLKS), focused on developing
treatments for cramps and spasms associated with the severe
neurological diseases of amyotrophic lateral sclerosis (ALS),
multiple sclerosis (MS) and peripheral neuropathies such as
Charcot-Marie-Tooth (CMT), today announced that the Company's
investigational new drug (IND) application for FLX-787 for patients
with ALS is effective which allows the Company to commence its U.S.
Phase 2 clinical trial of FLX-787 in ALS patients who suffer from
cramps as a consequence of the disease. The Company expects to
begin enrolling US patients this summer in this randomized,
controlled, double-blinded, parallel design study, referred to as
the COMMEND trial. In addition, the Company has exploratory Phase 2
studies currently ongoing in patients with MS and ALS in Australia.
FLX-787 is a small molecule co-activator of the TRPA1 and TRPV1 ion
channels, and has been shown to prevent and reduce the frequency
and intensity of muscle cramps in a human model of electrically
induced cramps.
“This open IND for FLX-787 allows us to initiate this Phase 2
multi-center trial, representing an important milestone for Flex
Pharma and starts the process of investigating other orphan
indications in neurology where cramps, spasms and spasticity impact
patients every day,” said Flex Pharma Chief Medical Officer Thomas
Wessel, M.D., Ph.D. “Based upon encouraging results in prior
randomized, controlled studies of FLX-787 in models of muscle
cramping in healthy volunteers, we are excited to advance FLX-787
into this Phase 2 clinical trial for ALS this summer.”
“Muscle cramps can have a severe impact on functional
performance and quality of life for patients with motor neuron
diseases like ALS,” indicated lead investigator Dr. Bj�rn Oskarsson
of the Mayo Clinic in Jacksonville, Florida. “Neurologists are
often confronted with a situation where the patient experiences
symptoms, and current treatments are either ineffective or have
limiting potential side effects. Flex Pharma’s FLX-787 may provide
a better approach to this challenging problem.”
“Very shortly, we also plan to submit a protocol to the IND for
a clinical trial of FLX-787 to treat patients with CMT, which would
enable us to begin another Phase 2 this summer, making FLX-787 one
of the most advanced novel compounds in development for CMT,” said
Flex Pharma R&D President Bill McVicar, Ph.D. “Together with
our ongoing exploratory Phase 2 studies in MS and ALS in Australia,
we are focused on the execution of these studies and expect to have
several data readouts in 2018.”
COMMEND Trial Design
This Phase 2 clinical trial is designed to evaluate FLX-787 in
patients with motor neuron disease (MND), focused on ALS, who
suffer from cramps. This randomized, controlled, double-blinded,
parallel design trial in the US will include a run-in period to
establish a baseline in cramp frequency. Patients will then be
randomized to 30 mg of FLX-787 administered three times a day or
control, for 28 days. Patients will be evaluated for changes in
cramp frequency as the primary endpoint, with a number of secondary
endpoints.
About Flex Pharma
Flex Pharma, Inc. is a biotechnology company that is developing
innovative and proprietary treatments for cramps and spasms
associated with the severe neurological diseases of ALS, MS and
peripheral neuropathies such as Charcot-Marie-Tooth (CMT). Flex
Pharma was founded by National Academy of Science members Rod
MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D.,
recognized leaders in the fields of ion channels and neurobiology,
along with Chair and CEO Christoph Westphal, M.D., Ph.D.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for
purposes of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. We may, in some cases, use terms
such as “predicts,” “believes,” “potential,” “proposed,”
“continue,” “estimates,” “anticipates,” “expects,” “plans,”
“intends,” “may,” “could,” “might,” “will,” “should” or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Forward-looking statements
include statements regarding our intentions, beliefs, projections,
outlook, analyses or current expectations concerning, among other
things: our expectations regarding current and future clinical
trials of our product candidates, including the success and timing
of these studies and our beliefs regarding the potential benefits
of our current product candidates. These forward-looking statements
are based on management’s expectations and assumptions as of the
date of this press release and are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include, without limitation: the
status, timing, costs, results and interpretations inherent in
conducting clinical trials; the fact that we rely on third parties
to manufacture and conduct the clinical trials, which could delay
or limit future development or regulatory approval; results from
ongoing and planned preclinical development; expectations of our
ability to make regulatory filings and obtain and maintain
regulatory approvals; results of early clinical studies as
indicative of results of future trials; the inherent uncertainties
associated with intellectual property; and other factors discussed
in greater detail under the heading “Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2016 and
subsequent filings with the Securities and Exchange
Commission (SEC). You are encouraged to read Flex Pharma’s
filings with the SEC, available at www.sec.gov, for a
discussion of these and other risks and uncertainties. Any
forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation
to update our forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this
press release.
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version on businesswire.com: http://www.businesswire.com/news/home/20170426005220/en/
Flex Pharma, Inc.Elizabeth Woo, 617-874-1829SVP, Investor
Relations & Corporate Communicationsirdept@flex-pharma.com
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